Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)

Phase 2

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: probiotics

• Registration Number: NCT03010735
• Lead Sponsor: China Agricultural University

Brief Summary

The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2017-02
• Study Completion: 2017-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age over 18 years old
• Patients who diagnosed as ESRD with hemodialysis
• Fixed hemodialysis cycle (average 3 times a week)
• Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.)
• Agree to sign the informed consent form

Exclusion Criteria

• Taking antibiotics or antifungal drugs within 30 days before the study
• Have serious allergic reaction to skim milk powder
• Researcher are not sure whether the subjects are willing or able to complete the study
• Subject participated in other research projects within two months before the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The patient take two placebo chewing tablet per day.
Probiotics	probiotics	The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics.

Primary Outcome Measures

Name	Time	Method
Changes in Microbiota-derived uremic toxin	6 months	follow up the patients at Month 0, 3, 6

Secondary Outcome Measures

Name	Time	Method
Changes in Fecal Microbiome	6 months	follow up the patients at Month 0, 3, 6
Changes in Fecal metabolites	6 months	follow up the patients at Month 0, 3, 6
Changes in Blood metabolites	6 months	follow up the patients at Month 0, 3, 6
Gastrointestinal Symptoms	6 months	follow up the patients at Month 0, 3, 6
The Kidney Disease Quality of Life	6 months	follow up the patients at Month 0, 3, 6
The Occurrence of Cardiovascular Event	6 month follow-up
Defecation questionnaire	6 months	follow up the patients at Month 0, 3, 6

Trial Locations

Locations (3)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

General Hospital of Chinese Armed Police Forces; 🇨🇳 Beijing, China

Peking University Aerospace Centre Hospital; 🇨🇳 Beijing, China